Phaco-ECP vs Phaco Alone in Primary Angle Closure

NCT ID: NCT04562402

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-16
• Study Completion Date: 2022-02-15

Brief Summary

Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.

Detailed Description

The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens.

Conditions

Glaucoma, Angle-Closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phacoemulsification with endoscopic cyclophotocoagulation

Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body.

Group Type: ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type: PROCEDURE

cataract surgery via phacoemulsification

Endoscopic cyclophotocoagulation

Intervention Type: PROCEDURE

Endoscopic ablation of the ciliary body

Phacoemulsification alone

Cataract extraction via phacoemulsification.

Group Type: ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type: PROCEDURE

cataract surgery via phacoemulsification

Interventions

Phacoemulsification

cataract surgery via phacoemulsification

Intervention Type: PROCEDURE

Endoscopic cyclophotocoagulation

Endoscopic ablation of the ciliary body

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age is above 40 years old.

2. A diagnosis of either PAC or PACG. PAC will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (PAS), without indentation (or prior documentation before a LPI has been performed) without any evidence of glaucomatous optic neuropathy. PACG will be defined as PAC along with an evidence of glaucomatous optic neuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing.

3. IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use of glaucoma medications or less than 21 mmHg with medications.

4. Patient is able to give an informed consent and tolerate a period of medication washout.

Exclusion Criteria

1. Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).

2. Previous ocular trauma.

3. A central corneal thickness that does not lie between 500 and 600 microns.

4. A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).

5. Presence of pseudoexfoliation.

6. Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.

7. Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020

8. Advanced glaucoma as defined by the Glaucoma Severity Staging System12 (mean deviation worse than -12.01 dB and at least one of the following: 1. On pattern deviation plot, greater than or equal to 50% but fewer than 75% of points depressed below the 5% level and greater than or equal to 25% but fewer than 50% of points depressed below 1% level 2. Any point within central 5 degrees with sensitivity < 0db 3. Both hemifields containing a point(s) with sensitivity < 15 dB within 5 degrees of fixation).

9. Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.

10. Pregnancy.

11. Inability to attend postoperative follow ups for a period of 12 months after surgery.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Khaled Eye Specialist Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Adi Al Owaifeer, MBBS

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adi Al Owaifeer, MBBS

Role: PRINCIPAL_INVESTIGATOR

King Khaled Eye Specialist Hospital

Ibrahim Alobaida, MD

Role: PRINCIPAL_INVESTIGATOR

King Khaled Eye Specialist Hospital

Locations

King Khaled Eye Specialist Hospital

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Muneera AlFutais

Role: CONTACT

mfutais@kkesh.med.sa

+966114849700 ext. 1374

Facility Contacts

Muneera AlFutais

Role: primary

mfutais@kkesh.med.sa

+966114849700 ext. 1374

Other Identifiers

1956-P

Identifier Type: -

Identifier Source: org_study_id